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The purpose of this study is to learn about the effects of a study medicine, WGI-0301 to find the best dose for treating solid tumors, and to see how safe and tolerable the study drug is for patients with solid tumors.
The study is also done to learn how the study drug is taken up by your body; this is called Pharmacokinetic (PK) studies and how the study drug affects the body; this is called Pharmacodynamics (PD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WGI-0301 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WGI-0301 | Drug | WGI-0301 is a lipid nanoparticle preparation of Archexin® for the treatment of advanced solid tumors. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Incidence and severity of treatment-related adverse events and serious adverse events | Approximately 16 months |
| Recommended Phase 2 Dose of WGI-0301 | Based on dose-limiting toxicities, the maximal tolerated dose and all other available safety, pharmacokinetic/pharmacodynamic data as assessed by the cohort review committee | Approximately 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve | Area under the plasma concentration time curve of WGI-0301 | Approximately 16 months |
| Maximum plasma concentration | Highest observed plasma concentration of WGI-0301 |
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Inclusion Criteria Subjects must meet all the following criteria to participate this study
Exclusion Criteria Subjects meet one or more of below criteria will be excluded
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Wang, Pharm. D, BCPS, CCRP | Contact | 2407965552 | chao.wang@thewogroup.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valkyrie Clinical Trials | Recruiting | Los Angeles | California | 90067 | United States |
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| Approximately 16 months |
| Time of maximum plasma concentration | Time to reach highest observed plasma concentration of WGI-0301 | Approximately 16 months |
| Half-life | Plasma concentration half-life of WGI-0301 | Approximately 16 months |
| The Oncology Institute of Hope and Innovation | Recruiting | Whittier | California | 90603 | United States |
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| University of Maryland, Greenebaum Comprehensive Cancer Center | Recruiting | Baltimore | Maryland | 21201 | United States |
|